UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of tumor antigen and immune response using clinical samples
Title of the study (Brief title)	Analysis of tumor antigen and immune response using clinical samples
Region	Japan

Condition
Condition	cancer patients and healthy volunteer
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Oral surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze tumor antigen expression and immune responses in cancer patients and healthy volunteer
Basic objectives2	Others
Basic objectives -Others	To select populations suitable for cancer immunotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tumor antigen expression and immune responses
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	cancer patients or healthy volunteer
Key exclusion criteria	none
Target sample size	300

Research contact person
Name of lead principal investigator	Shinichi Kageyama
Organization	Mie University Graduate School of Medicine
Division name	Immuno-Gene Therapy
Address	2-174, Edobashi, Tsu, Mie, 514-8507 Japan
TEL	059-231-5187
Email	kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Shinichi Kageyama
Organization	Mie University Graduate School of Medicine
Division name	Immuno-Gene Therapy
Address	2-174, Edobashi, Tsu, Mie 514-8507 Japan
TEL	059-231-5187
Homepage URL
Email	kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	Mie University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 02 Month 07 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://clincancerres.aacrjournals.org/content/21/10/2268.long
Results
Other related information	none

Management information
Registered date	2014 Year 05 Month 20 Day
Last modified on	2018 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016316